Skip to main content
OpenTrials
Completed

NCT Number: NCT05511922

PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

KalVista Investigative Site, Campbelltown, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial.
  • Patient is currently participating in KVD900-302.
  • Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable.
  • Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit.

Exclusion criteria

  • Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.

Treatment and study plan

KVD900 600 mg

Drug

KVD900 Tablet 600 mg (2 x 300 mg)

Drug: KVD900 300 mg

Drug

KVD900 Tablet 300 mg

Primary outcomes

  1. Pharmacokinetics - Cmax

    Time frame: Up to 6 hours after IMP administration

  2. Pharmacokinetics - Tmax

    Time frame: Up to 6 hours after IMP administration

  3. Pharmacokinetics - AUC

    Time frame: Up to 6 hours after IMP administration

Sponsors and collaborators

Lead sponsor

KalVista Pharmaceuticals, Ltd.

Industry

Registry information

Official study title

A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.